journal
Journals Pharmacoepidemiology and Drug ...

Pharmacoepidemiology and Drug Safety

https://read.qxmd.com/read/38837561/use-of-methylphenidate-and-reporting-of-valvular-heart-disease-global-pharmacovigilance-analysis-in-children-and-adults
#1
JOURNAL ARTICLE
Estelle Ayme-Dietrich, Florentia Kaguelidou, Gilles Bertschy, Laurent Chouchana
INTRODUCTION: Methylphenidate (MPH) is a common treatment of attention-deficit/hyperactivity disorder (ADHD). Concern has been raised regarding its cardiovascular safety, partly in relation with its micromolar affinity for the 5-HT2B receptor, whose activation may result in valvular heart disease (VHD). METHODS: To explore the association between the use of MPH and VHD reporting, we performed a disproportionality analysis within the WHO global safety database (VigiBase) using data, since inception until March 6th 2024, from: (i) the full database and (ii) different age groups (children/adolescents 6-17 years; adults 18-64 years)...
June 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38825963/use-of-electronic-health-record-data-to-examine-administrations-of-pro-re-nata-analgesics-during-hip-fracture-post-acute-care
#2
JOURNAL ARTICLE
Melissa R Riester, Yuan Zhang, Kaleen N Hayes, Francesca L Beaudoin, Andrew R Zullo
PURPOSE: Medications prescribed to older adults in US skilled nursing facilities (SNF) and administrations of pro re nata (PRN) "as needed" medications are unobservable in Medicare insurance claims. There is an ongoing deficit in our understanding of medication use during post-acute care. Using SNF electronic health record (EHR) datasets, including medication orders and barcode medication administration records, we described patterns of PRN analgesic prescribing and administrations among SNF residents with hip fracture...
June 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38825961/use-of-privacy-preserving-record-linkage-to-examine-the-dispensing-of-pharmaceutical-benefits-scheme-medicines-to-pregnant-women-in-western-australia
#3
JOURNAL ARTICLE
Erin Kelty, Michele Hansen, Sean Randall, Dylan Gration, Gareth Baynam, David B Preen
PURPOSE: Medications are commonly used during pregnancy to manage pre-existing conditions and conditions that arise during pregnancy. However, not all medications are safe to use in pregnancy. This study utilized privacy-preserving record linkage (PPRL) to examine medications dispensed under the national Pharmaceutical Benefits Scheme (PBS) to pregnant women in Western Australia (WA) overall and by medication safety category. METHODS: In this retrospective, cross-sectional, population-based study, state perinatal records (Midwives Notification Scheme) were linked with national PBS dispensing data using PPRL...
June 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38798093/the-antiretroviral-pregnancy-registry-three-decades-of-prospective-monitoring-for-birth-defects
#4
JOURNAL ARTICLE
Jessica D Albano, Angela E Scheuerle, D Heather Watts, Karen P Beckerman, Lynne M Mofenson, Andreas Pikis, Vani Vannappagari, Daniel Seekins, Taylor S Cook, Hugh Tilson
PURPOSE: Antiretrovirals (ARVs) are life-saving drugs used for the treatment and prevention of HIV infection and antiviral drugs (AVs) for the treatment of chronic HBV infection. ARVs have proven highly effective in reducing perinatal HIV transmission, however the risk of birth defects from prenatal exposure to ARVs/AVs is an ongoing concern. The Antiretroviral Pregnancy Registry (APR), an international, prospective exposure-registration cohort study, monitors ARV and AV use in pregnancy for early signals of teratogenicity...
June 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38783553/the-impact-of-more-restrictive-hydrocodone-rescheduling-on-unintentional-pediatric-opioid-exposures
#5
JOURNAL ARTICLE
Celeste Mallama, Sara Karami, Di Zhang, Yueqin Zhao, Yuze Yang, Corinne Woods, Yulan Ding, Tamra Meyer, Jana McAninch
PURPOSE: To evaluate the impact of rescheduling hydrocodone combination products (HCPs) from schedule III of the Controlled Substances Act to the more restrictive schedule II on unintentional pediatric exposures (≤5 years old). METHODS: Using U.S. data on outpatient retail pharmacy dispensing, emergency department (ED) visits, and poison center (PC) exposure cases, we assessed trends in prescriptions dispensed and unintentional pediatric exposure cases involving hydrocodone (rescheduled from III to II) compared to oxycodone (schedule II) and codeine (schedule III for combination products) using descriptive and interrupted time-series (ITS) analyses during the 16 quarters before and after the October 2014 rescheduling of HCPs...
June 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38783423/correlation-of-drug-dose-estimated-from-national-prescription-registers-with-mean-blood-level-of-antiseizure-medication-in-pregnancy
#6
JOURNAL ARTICLE
Jakob Christensen, Betina Trabjerg, Julie Werenberg Dreier
PURPOSE: The purpose was to examine the correlation of antiseizure medication drug dose estimated from prescription fill records from prescription registers with blood levels during pregnancy. METHODS: We conducted a Nation-wide study of mothers who gave birth in Denmark between 1 January 2014 and 31 December 2018 using data from Danish Prescription and Laboratory Registers. We identified mothers with blood level measurements of antiseizure medication. The main exposure was estimated antiseizure medication dosage estimated from pregnancy-filled prescriptions in the Danish Prescription Register...
June 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38783417/medication-related-incidents-in-acute-care-hospitals-among-different-age-groups-an-analysis-of-national-patient-safety-report-data
#7
JOURNAL ARTICLE
Ji Min Han, Kyu-Nam Heo, A Jeong Kim, Ah Young Lee, Sangil Min, Young-Mi Ah, Ju-Yeun Lee
PURPOSE: This study aimed to perform a nationwide analysis of medication errors (MEs) from hospitals using national reporting system data and to compare the ME patterns among different age groups. METHODS: We analyzed medication-related incidents in acute care hospitals reported to the Korean Patient Safety Reporting and Learning System (KOPS), which is a patient safety reporting system, from July 2016 to December 2020. The stages of the medication use process, type of errors, medication class involved in MEs, and degree of harm were analyzed...
June 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38783416/adherence-with-statins-and-all-cause-mortality-in-days-with-high-temperature
#8
JOURNAL ARTICLE
Gabriel Chodick, Ran S Rotem, Todd A Miano, Warren B Bilker, Sean Hennessy
PURPOSE: It has been suggested that statins may exert thermo-protective effects that can reduce mortality on hot days. We aimed to examine the relationship between statin adherence and mortality in days with high temperature. METHODS: Utilizing data from a prior historical new-user cohort study, we analyzed a cohort of 229 918 individuals within a state-mandated health provider in Israel who initiated statin therapy between 1998 and 2006. Adherence to statins was assessed through the mean proportion of days covered (PDC) with statins during the follow-up period...
June 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38783412/opensafely-a-platform-for-analysing-electronic-health-records-designed-for-reproducible-research
#9
JOURNAL ARTICLE
Linda Nab, Andrea L Schaffer, William Hulme, Nicholas J DeVito, Iain Dillingham, Milan Wiedemann, Colm D Andrews, Helen Curtis, Louis Fisher, Amelia Green, Jon Massey, Caroline E Walters, Rose Higgins, Christine Cunningham, Jessica Morley, Amir Mehrkar, Liam Hart, Simon Davy, David Evans, George Hickman, Peter Inglesby, Caroline E Morton, Rebecca M Smith, Tom Ward, Thomas O'Dwyer, Steven Maude, Lucy Bridges, Ben F C Butler-Cole, Catherine L Stables, Pete Stokes, Chris Bates, Jonny Cockburn, Frank Hester, John Parry, Krishnan Bhaskaran, Anna Schultze, Christopher T Rentsch, Rohini Mathur, Laurie A Tomlinson, Elizabeth J Williamson, Liam Smeeth, Alex Walker, Sebastian Bacon, Brian MacKenna, Ben Goldacre
Electronic health records (EHRs) and other administrative health data are increasingly used in research to generate evidence on the effectiveness, safety, and utilisation of medical products and services, and to inform public health guidance and policy. Reproducibility is a fundamental step for research credibility and promotes trust in evidence generated from EHRs. At present, ensuring research using EHRs is reproducible can be challenging for researchers. Research software platforms can provide technical solutions to enhance the reproducibility of research conducted using EHRs...
June 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38783407/transparency-reproducibility-and-replicability-of-pharmacoepidemiology-studies-in-a-distributed-network-environment
#10
JOURNAL ARTICLE
Ashish Rai, Judith C Maro, Sarah Dutcher, Patricia Bright, Sengwee Toh
PURPOSE: Our objective is to describe how the U.S. Food and Drug Administration (FDA)'s Sentinel System implements best practices to ensure trust in drug safety studies using real-world data from disparate sources. METHODS: We present a stepwise schematic for Sentinel's data harmonization, data quality check, query design and implementation, and reporting practices, and describe approaches to enhancing the transparency, reproducibility, and replicability of studies at each step...
June 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38773801/temporal-trends-in-use-of-antisecretory-agents-among-patients-administered-clopidogrel-based-dual-antiplatelet-therapy-after-percutaneous-coronary-intervention
#11
JOURNAL ARTICLE
Yonghyuk Lee, Hye-Jeong Choi, Susin Park, Nam Kyung Je
BACKGROUND: Antisecretory drugs are commonly prescribed with clopidogrel-based dual antiplatelet therapy (DAPT) to prevent gastrointestinal bleeding in high-risk patients after percutaneous coronary intervention (PCI). However, omeprazole and esomeprazole (inhibiting proton pump inhibitors [PPIs]) may increase cardiovascular event rates on co-administration with clopidogrel. This study aimed to examine trends in the use of antisecretory agents in patients administered clopidogrel-based DAPT and the concomitant use of clopidogrel and inhibiting PPIs...
June 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38773798/calculating-daily-dose-in-the-observational-medical-outcomes-partnership-common-data-model
#12
JOURNAL ARTICLE
Theresa Burkard, Kim López-Güell, Artem Gorbachev, Lucía Bellas, Annika M Jödicke, Edward Burn, Maria de Ridder, Mees Mosseveld, Jasmine Gratton, Sarah Seager, Dina Vojinovic, Miguel Angel Mayer, Juan Manuel Ramírez-Anguita, Angela Leis Machín, Marek Oja, Raivo Kolde, Klaus Bonadt, Daniel Prieto-Alhambra, Chistian Reich, Martí Català
PURPOSE: We aimed to develop a standardized method to calculate daily dose (i.e., the amount of drug a patient was exposed to per day) of any drug on a global scale using only drug information of typical observational data in the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM) and a single reference table from Observational Health Data Sciences And Informatics (OHDSI). MATERIALS AND METHODS: The OMOP DRUG_STRENGTH reference table contains information on the strength or concentration of drugs, whereas the OMOP DRUG_EXPOSURE table contains information on patients' drug prescriptions or dispensations/claims...
June 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38741353/non-adherence-and-non-persistence-with-antiretroviral-treatment-in-belgium-a-real-world-evaluation-using-a-pharmacy-database-2018-2021
#13
JOURNAL ARTICLE
Dieudonné Ilboudo, Patricia Mbouche, Agnès Sommet, Philippe Van Wilder, Fati Kirakoya-Samadoulougou
PURPOSE: To evaluate the real-world rates of non-adherence and non-persistence to antiretroviral therapy (ART) among treatment-naïve adult patients with HIV after a 12-month follow-up period in Belgium. METHODS: A retrospective analysis of longitudinal pharmacy claims was conducted using the Pharmanet database from January 1, 2018, to December 31, 2021. Non-adherence was assessed over 12 months and reported as the proportion of days covered below the 80% threshold...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38724471/describing-diversity-of-real-world-data-sources-in-pharmacoepidemiologic-studies-the-diverse-scoping-review
#14
REVIEW
Rosa Gini, Romin Pajouheshnia, Helga Gardarsdottir, Dimitri Bennett, Lin Li, Claudia Gulea, Angelika Wientzek-Fleischmann, Marloes T Bazelier, Mehmet Burcu, Caitlin Dodd, Carlos E Durán, Sigal Kaplan, Stephan Lanes, Karine Marinier, Giuseppe Roberto, Kanaka Soman, Xiaofeng Zhou, Robert Platt, Soko Setoguchi, Gillian C Hall
PURPOSE: Real-world evidence (RWE) is increasingly used for medical regulatory decisions, yet concerns persist regarding its reproducibility and hence validity. This study addresses reproducibility challenges associated with diversity across real-world data sources (RWDS) repurposed for secondary use in pharmacoepidemiologic studies. Our aims were to identify, describe and characterize practices, recommendations and tools for collecting and reporting diversity across RWDSs, and explore how leveraging diversity could improve the quality of evidence...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38720425/emulation-of-randomized-trials-of-direct-oral-anticoagulants-with-claims-data-and-implications-for-new-factor-xi-inhibitors
#15
JOURNAL ARTICLE
Shirley V Wang, Kueiyu Joshua Lin, Sebastian Schneeweiss
Direct oral anticoagulants (DOACs) revolutionized the management of thromboembolic disorders. Clinical care may be further improved as Factor XIs undergo large-scale outcome trials. What role can non-randomized database studies play in expediting understanding of these drugs in clinical practice? The RCT-DUPLICATIVE Initiative emulated the design of eight DOAC randomized clinical trials (RCT) using non-randomized claims database studies. RCT study design parameters and measurements were closely emulated by the database studies and produced highly concordant results...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38720413/the-impact-of-hospitalization-on-inappropriate-prescribing-and-polypharmacy-in-older-patients-a-descriptive-cross-sectional-study
#16
JOURNAL ARTICLE
Ori Weiss, Andy Eyre, Danny Alon Ellenbogen, Gideon Y Stein
BACKGROUND: Polypharmacy and the use of potentially inappropriate medications (PIMs) in older individuals are widespread phenomena that are associated with an increase in morbidity and mortality. The Beers Criteria is a tool that helps to identify patients that are prescribed with PIMs, thereby reducing the risk of associated harm. Amongst other populations, the criteria identify drugs that should not be used by the majority of older patients. AIM: Determining the proportion of older inpatients who were discharged from hospitalization with polypharmacy (a prescription for more than seven drugs), or with a PIM as defined by the Beers Criteria...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38720409/do-efficacy-results-obtained-from-randomized-controlled-trials-translate-to-effectiveness-data-from-observational-studies-for-relapsing-remitting-multiple-sclerosis
#17
REVIEW
Stefan Verweij, Wouter Ahmed, Guiling Zhou, Dimitris Mavridis, Stavros Nikolakopoulos, Andre J Elferink, Katrien Oude Rengerink, Maarten J Bijlsma, Peter G M Mol, Eelko Hak
BACKGROUND: Randomized controlled trials are considered the gold standard in regulatory decision making, as observational studies are known to have important methodological limitations. However, real-world evidence may be helpful in specific situations. This review investigates how the effect estimates obtained from randomized controlled trials compare to those obtained from observational studies, using drug therapy for relapsing-remitting multiple sclerosis as an example. STUDY DESIGN AND SETTING: A systematic review of randomized controlled trials and observational studies was conducted...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38720405/application-of-multiple-validated-algorithms-for-identifying-incident-breast-cancer-among-individuals-with-atopic-dermatitis
#18
JOURNAL ARTICLE
Adriana Campos, Ramya Ramasubramanian, Cherise Wong, Andrea Fleisch Marcus
PURPOSE: Validated algorithms (VAs) in insurance claims databases are often used to estimate the prevalence and incidence of comorbidities and evaluate safety signals. However, although they are then used in different data sources or subpopulations from those in which they were developed the replicability of these VAs are rarely tested, making their application and performance in these settings potentially unknown. This paper describes testing multiple VAs used to identify incident breast cancer cases in a general population and in an indication-specific population, patients with atopic dermatitis (AD)...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38720402/matching-study-design-to-prescribing-intention-the-prevalent-new-user-design-for-studying-abuse-deterrent-formulations-of-opioids
#19
JOURNAL ARTICLE
Bethany L DiPrete, GYeon Oh, Daniela C Moga, Nabarun Dasgupta, Svetla Slavova, Emily Slade, Chris Delcher, Brian W Pence, Shabbar I Ranapurwala
PURPOSE: In drug studies, research designs requiring no prior exposure to certain drug classes may restrict important populations. Since abuse-deterrent formulations (ADF) of opioids are routinely prescribed after other opioids, choice of study design, identification of appropriate comparators, and addressing confounding by "indication" are important considerations in ADF post-marketing studies. METHODS: In a retrospective cohort study using claims data (2006-2018) from a North Carolina private insurer [NC claims] and Merative MarketScan [MarketScan], we identified patients (18-64 years old) initiating ADF or non-ADF extended-release/long-acting (ER/LA) opioids...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38719731/risk-of-acute-pancreatitis-among-new-users-of-empagliflozin-compared-to-sulfonylureas-in-patients-with-type-2-diabetes-a-post-authorization-safety-study
#20
COMPARATIVE STUDY
Soulmaz Fazeli Farsani, Kristy Iglay, Ling Zhang, Christian Niyonkuru, Laurieann Nessralla, Cynthia J Girman
PURPOSE: This study was undertaken to evaluate the potential risk of acute pancreatitis with empagliflozin in patients with type 2 diabetes (T2D) newly initiating empagliflozin. METHODS: Data from two large US claims databases were analyzed in an observational study of patients with T2D receiving metformin who were newly prescribed empagliflozin versus sulfonylurea (SU). Because dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists have been associated with the risk of acute pancreatitis in some studies, patients on these agents were excluded...
May 2024: Pharmacoepidemiology and Drug Safety
journal
journal
31040
1
2
Fetch more papers »
Fetching more papers... Fetching...
Remove bar
Read by QxMD icon Read
×

Save your favorite articles in one place with a free QxMD account.

×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"

We want to hear from doctors like you!

Take a second to answer a survey question.